Overview over preclinical safety (PCS)

This overview has several parts, namely

• General aspects of PCS including – among others – some remarks on specialties, objectives and risk assessment
• Substances and routes used in PCS
• Keywords often used in PCS assessment
• The most important guidelines for PCS assessment, including references
• Some topics of the regulations used in PCS with remarks on some regulatory milestones, consultations with regulatory authorities and good laboratory practice
• Type, duration and dose of regulatory studies for PCS
• Procedures with summaries of regulatory requirements for PCS of drugs